Food & Drug Administration (FDA) (CLOSED)
Most Recent Update 10/02 (See end of document)
9/01 Update:
United States v. Para Tech Industries, Inc., Therasys, Inc., Paul
F. Fulk, and Earnie S. Philpot, 00 CR 77 (S.D. Ohio) (Chief Judge
Walter Herbert Rice)
On Thursday, December 21, 2000, Para Tech Industries, Inc. ("Para Tech"),
and Therasys, Inc. ("Therasys"), pled guilty in Dayton, Ohio, to one
felony count of conspiring to defraud the United States Food and Drug
Administration ("FDA") of its authority to regulate the distribution
of medical devices. The charge to which Para Tech and Therasys pled
guilty relates to the companies' distribution of an unapproved medical
device known as the CTD-Mark I, which the companies marketed as being
a treatment device for carpel tunnel syndrome. At the plea hearing,
the companies admitted that from at least December 1994, the owners
and officers of Para Tech and Therasys knew that the CTD-Mark I had
not received clearance from the FDA, and was not approved to be sold
as a treatment device for carpel tunnel syndrome. The companies further
admitted that from at least on or about February 16, 1995, through on
or about August 28, 1999, the companies' owners and officers agreed
among themselves to deceive the FDA by making false statements regarding
Para Tech's continued manufacture, sale, and shipment in interstate
commerce of the CTD-Mark I devices. At the same time, Paul F. Fulk,
the Chief Executive Officer of both companies, and Earnie S. Philpot,
an officer and director of both companies, pled guilty to a felony count
charging them with conspiring to obstruct a pending FDA inspection.
At the guilty plea hearing, Paul Fulk and Ernest Philpot admitted that
during an FDA inspection in December 1995 they attempted to conceal
from the FDA investigators the fact that both Para Tech and Therasys
were marketing and selling CTD-Mark I devices in interstate commerce
without FDA approval. No sentencing date has yet been set.
Victim Notification and Restitution Begins
On February 2, 2001, a mailing was sent to all doctors and chiropractors
who may have purchased, leased, or had refurbished a CTD-Mark I, advising
them that they may be entitled to restitution if they meet the following
criteria:
1. They purchased, leased, or refurbished a CTD-Mark I device prior
to August 12, 1999, for the purpose of treating patients with carpal
tunnel syndrome;
and
2. They were not aware that the CTD-Mark I device was not approved
or cleared by the FDA for treatment of patients.
To read a copy of the notice, click here.
Accompanying the notice was a form explaining the type(s) of compensation
that victims may be entitled to receive. To read this form, click here.
To be eligible for restitution, any doctor or chiropractor who purchased,
leased, or had refurbished a CTD-Mark I is required to complete a declaration
providing sufficient information to the United States Probation Office
such that a determination can be made as to whether the doctor or chiropractor
is eligible for restitution. This declaration must be sent to:
Ms. Margarette R. Foster
United States Probation Office
200 West 2nd Street
Room 702
Dayton, OH 45402
(937) 512-1468
(937) 225-2755 (facsimile)
by no later than February 16, 2001. To access this declaration, click
here.
12/01 Update:
No change in status.
3/02 Update:
Para Tech CEO Sentenced to One Year in Prison; Para
Tech and Therasys Ordered to Pay $211,102.30 in Restitution.
On March 11, 2002, Chief Judge Walter Herbert Rice sentenced
Paul F. Fulk to one year in prison and ordered Fulk to pay a $3,000
fine in connection with his efforts to obstruct a 1995 FDA inspection
of Para Tech Industries, Inc., and Therasys, Inc. Judge Rice sentenced
co-conspirator, Earnie Philpot, to three years' probation, with the
first six months on home confinement and further ordered Philpot to
pay a $2,000 fine.
Para Tech Industries and Therasys were ordered to pay
$211,102.30 in restitution to chiropractors who purchased the CTD-Mark
I, believing it had been approved by the FDA for treatment of carpal
tunnel syndrome. Although Judge Rice ordered the two corporate defendants
to pay restitution, the United States cannot predict when they will
actually make such payments.
It should be noted that not all of the chiropractors who
filed restitution claims were ultimately found to be eligible for restitution.
Due to the circumstances surrounding the case, the only chiropractors
who were eligible for restitution were those individuals who purchased
CTD-Mark I devices that had been sold by Para Tech or Therasys between
February 15, 1995, and August 12, 1999. Many of the CTD-Mark I devices
purchased by chiropractors who filed restitution claims were sold by
Para Tech or Therasys prior to February 16, 1995; as a
result, those chiropractors were not eligible to receive restitution.
In the near future, the United States will be sending
letters to all chiropractors who filed restitution claims. These letters
either (1) will advise individual chiropractors that the corporate defendants
were ordered to pay restitution to them in a given amount, or (2) will
explain to the individual chiropractors why they were not eligible to
receive restitution.
Any questions about this case may be addressed to:
Paralegal Specialist/Para Tech Industries Inc.
Consumer Protection Branch
United States Department of Justice
P.O. Box 386
Washington, DC 20044
6/02 Update:
No change in status.
10/02 Update:
All letters to chiropractors, referenced in 3/02 Update, have been
sent out.
